JP2020174978A - Injection needle assembly - Google Patents

Abstract

To provide an injection needle assembly which can alleviate pain during injection and can charge a small amount of content easily even for the skin having hair.SOLUTION: An injection needle assembly 1 has an end of an injection cylinder engaged and injects content, and includes: a connection distribution part 10 which has a cylindrical fitting collar 11 opening at one end side so that the end of the injection cylinder is engaged and a body 12 where the other end and the one end of the fitting collar 11 are joined, which expands more in a width direction than an outer diameter of the fitting collar 11, the other end opens, and becomes a fitting space; and a needle support part 20 which has a plurality of nozzles 22a to 22e fixing a plurality of needles 3a to 3e in a state that they are arranged in the width direction and a frame body 21 one end side of which is engaged and fixed inside the fitting space of the body part 12 of the connection distribution part 10 and which encircles a part of the plurality of nozzles 22a to 22e so that the plurality of nozzles 22a to 22e project from the other end side.SELECTED DRAWING: Figure 3

Description

The present invention relates to a needle assembly.

In a syringe, injection with a single needle is common. However, for example, when the same drug solution is to be spread over a wide area, injection with a single needle requires many injection operations, and the number of times of pain occurs increases.

Therefore, as a technique for injecting a plurality of needles at the same time, for example, a drug solution injection needle in which three needles are arranged in an equilateral triangle shape on the premise of vertical puncture has been proposed in Patent Document 1.

On the other hand, Patent Document 2 proposes a multi-needle plate device having a plurality of injection needles so that a sample is simultaneously injected through a plurality of needles in parallel.

International Publication 2015/064031 Japanese Unexamined Patent Publication No. 62-26075

However, the configuration of Patent Document 1 is based on the premise that the skin is punctured perpendicularly to the skin, and the skin cannot be punctured diagonally. In addition, since the needles are arranged in a polygonal shape, for example, when puncturing the skin in which hair or body hair is densely present, the hair enters between the polygonal surface on which the needles are arranged and the skin. Since the hair interferes with the puncture, it was necessary to hold down the hair at the injection site.

Further, since the multi-needle plate device of Patent Document 2 is configured to be integrated except for the metal needle, fine processing with resin cannot be performed, the device becomes large, and a small amount of contents can be injected. Was not suitable. In addition, since a needle having the same thickness as the needle of the injection needle for a single needle is applied to the multi-needle plate device, the injection amount per needle does not change in this device, and the injection amount increases as a whole, and the increase increases. Since the injection volume is injected at one time, pain during injection may increase.

Therefore, in view of the above circumstances, an object of the present invention is to provide an injection needle assembly capable of easily administering a small amount of contents with reduced pain at the time of injection even on skin having hair. To do.

In order to solve the above problems, in one aspect of the present invention,
A needle assembly in which the tip of a syringe is fitted to inject the contents.
A tubular mounting collar that is open to one end so that the tip of the tip of the injection tube is fitted, and the other end of the mounting collar is connected to one end in the width direction from the outer diameter of the mounting collar. A connecting and distributing part having a main body part that extends to the other side and has an opening at the other end to serve as a mounting space.
A plurality of nozzles for fixing a plurality of needles in a lined state in the width direction, and one end side of the connecting and distributing portion are fitted and fixed inside the mounting space of the main body portion, and the plurality of needles are fixed from the other end side. A needle support portion having a frame body surrounding a part of the plurality of nozzles is provided so that the nozzles project.
Needle assembly, provided.

According to one aspect, in the needle assembly, a small amount of content can be easily administered, even on hairy skin, with reduced pain during injection.

The whole view of the injection needle assembly which concerns on embodiment of this invention. An exploded explanatory view of attaching the injection needle assembly of the present invention to a syringe. An overall view and a sectional view illustrating the dimensions of the injection needle assembly of the present invention. A side view and a cross-sectional exploded view of the injection needle assembly of FIG. Explanatory drawing of connected distribution part. Explanatory drawing of a needle support part. The perspective explanatory view of the attachment of the connection distribution part and the needle support part. Explanatory drawing of the cap. The figure explaining the single needle of the comparative example in the 1st experimental example, and the multi-needle of the 1st constitution example of this invention. The figure which shows the execution condition of the comparative example in the 2nd experimental example. The figure which shows the carrying-out condition of this invention in 2nd experimental example. The figure which shows the comparative example and the evaluation result of the pain of this invention in the 2nd experimental example. In the third experimental example, the graph which shows the discharge amount of each needle at the time of discharging water with the multi-needle of this invention, and the average discharge amount of each time. In the third experimental example, the graph which shows the discharge amount of each needle at the time of discharging the cell fluid by the multi-needle of this invention, and the average discharge amount of each time.

Hereinafter, embodiments for carrying out the present invention will be described with reference to the drawings. In each of the drawings below, the same components may be designated by the same reference numerals and duplicate description may be omitted.

The present invention is an example of an injection needle in which the tip of an injection cylinder is fitted to inject contents such as liquid and fluid, and a multi-needle type injection needle assembly (injection needle assembly) in which a plurality of needles are integrated. Body, also called injection needle device).

<Overall configuration example>
FIG. 1 is an overall view of the injection needle assembly 1 according to the embodiment of the present invention.

The injection needle assembly 1 according to the embodiment of the present invention includes a connecting distribution unit 10 into which the tip of the injection cylinder is fitted, and a plurality of nozzles 22a to 22e for fixing the five needle tubes (needle) 3a to 3e. The needle support portion 20 is provided.

FIG. 2 is an exploded explanatory view of attaching the injection needle assembly 1 of the present invention to the syringe 80.

The syringe 80 includes a syringe tube 84 and a pusher 88. The injection cylinder (cylinder) 84 houses the contents, and the pusher 88 is inserted. Specifically, the injection cylinder 84 includes an outer cylinder portion 85 for accommodating the contents, a flange 86 provided at the rear end of the outer cylinder portion 85, and a cylinder tip 87 which is a tip portion.

Here, as the syringe 80 to which the injection needle assembly 1 of the present invention is attached, for example, it is preferable to use a syringe having a volume of 1 mL. Such a 1 mL syringe 80 allows 10 100 μL injections and 6 166 μL injections. Alternatively, a syringe having a volume of 2 mL, 5 mL or 10 mL can be used as the attachment destination of the needle assembly 1. Depending on the specific use of the needle assembly 1, the syringe may have a larger or smaller volume.

The injection needle assembly 1, which is the injection needle of the present invention, is connected to the tip 87 of the injection cylinder 84. Specifically, the needle assembly 1 has a tubular mounting collar 11 that is externally fitted to the tip 87 of the syringe barrel 84. When the injection needle assembly 1 is attached to the syringe 80, the tip 87 of the injection cylinder 84 is inserted into and engaged with the mounting collar 11 of the injection needle assembly 1. A syringe having a structure that locks the mounting collar 11 of the needle assembly 1 and the tip 87 of the injection cylinder 84 so as not to be easily removed may be used.

Here, it is preferable that the diameter (number of gauges) of the needle tubes 3a to 3e, which is applied to the injection needle assembly 1 of the present invention, is in the range of 18 to 34G and 20 to 32G. Further, it is more preferably 26G, 27G, 30G or 31G.

Examples of the constituent materials of the needles 3a to 3e include metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and plastic materials.

The contents of the pusher 88 (plunger) are released from the syringe by moving in the outer cylinder portion 85 of the injection cylinder 84 when the head (rear portion) 88h is pressed. A gasket 89, which is a thin plate-shaped rubber packing (sealing element) for preventing liquid leakage and foreign matter from entering, is adhered to the tip of the pusher 88.

In addition, the cap 40 may be attached to cover the needle assembly 1 of the present invention. The cap 40 is configured to cover the injection needle assembly 1, and the portion that contacts and covers the connecting and distributing portion 10 is a thick fixing portion 41, and does not contact the nozzles 22a to 22e and the needle tubes 3a to 3e. The portion covered with is a cover portion 42 having a cross-sectional area smaller than that of the fixed portion 41.

<Disassembly configuration>
Next, each component of the injection needle assembly 1 of the present invention will be described with reference to FIGS. 3 to 7. FIG. 3 is an explanatory view of the injection needle assembly 1 of the present invention. In FIG. 3, (a) is an overall view, and (b) is a cross-sectional view taken along the line AA of FIG. 3 (a).

FIG. 4 is an exploded view of the injection needle assembly 1 of FIG. In the injection needle assembly 1 of FIG. 4, (a) is a front exploded view, (b) is a side exploded sectional view, and (c) is the needle support portion 20 shown by the circle B of FIG. 4 (b). It is an enlarged view of a part.

With reference to FIGS. 3B and 4, the injection needle assembly 1 has a connecting distribution section 10, a needle support section 20, and needle tubes (needle) 3a to 3e.

Specifically, the connection distribution unit 10 has a mounting collar 11 and a main body unit 12. The mounting collar 11 is a tubular member that is open to one end (upper side in FIG. 4) so that the tip 87 at the tip of the injection tube 84 is fitted. The main body 12 has one end connected to the other end of the mounting collar 11 and is wider in the width direction (Y direction) than the outer diameter D111 of the mounting collar 11 (see FIG. 5C), and the other end (FIG. 5). The lower side of 4) is opened to form a mounting space S (see FIGS. 4 (b) and 7 (b)).

Further, the needle support portion 20 has a frame body 21 and a plurality of nozzles 22a to 22e. The plurality of nozzles 22a to 22e are fixed in a state where the plurality of needle tubes 3a to 3e are arranged in the width direction.

By arranging a plurality of needle tubes 3a to 3e in one direction, the syringe 80 equipped with the injection needle assembly 1 of the present invention punctures the needle tubes 3a to 3e in a state of being tilted with respect to the skin. The contents can be administered.

Further, the frame body 21 is fixed by fitting one end side (upper side of FIG. 4) into the inside of the mounting space S of the main body portion 12 of the connection distribution unit 10, and a plurality of frame bodies 21 are fixed from the other end side (lower side of FIG. A part (upper part) of the plurality of nozzles 22a to 22e is surrounded so that a part of the nozzles 22a to 22e protrudes. As shown in FIG. 4, the nozzles 22a to 22e and the frame 21 are integrally configured.

Further, referring to FIG. 3B, the needle tip of the needle tube 3c is open to one surface in the longitudinal direction. As shown in FIG. 3A, the opening directions of the needle tips of the plurality of needles 3a to 3e are all fixed so as to be the same direction. Therefore, when the content is injected from the syringe 80 equipped with the injection needle assembly 1 of the present invention, the content can be injected so as to be parallel to the subcutaneous portion in the same direction.

Here, referring to FIG. 4B, the height from the upper end to the lower end of the frame body 21 of the needle support portion 20 is substantially the same as the height of the mounting space S of the main body portion 12. For example, the height of the mounting space is 0.5 mm to 3.0 mm. With this dimension, the nozzles 22a to 22e can be projected from under the main body 12 without projecting the frame body 21.

Further, since the needle support portion 20 is fitted inside the connecting and distributing portion 10, as shown in FIG. 3B, the outer diameter OD22 of the nozzles 22a to 22e (see FIG. 6C) in the lateral direction. ) Is shorter than the length (depth) of the main body portion 12 of the connecting distribution portion 10 in the lateral direction. Therefore, since the nozzles 22a to 22e on the tip side in the depth direction are thinner than the main body 12, the syringe 80 is tilted and punctured in a direction orthogonal to the arrangement direction of the needles 3a to 3e (FIG. 3B). Even when puncturing so as to tilt), the nozzles 22a to 22e are less likely to come into contact with the skin, and even if the skin has hair, the nozzles 22a to 22e are less likely to interfere with the hair.

FIG. 5 is an explanatory diagram of the connected distribution unit 10. In FIG. 5, (a) is a plan view, (b) is a front view, (c) is a side view, and (d) is a bottom view.

With reference to FIG. 5, the mounting collar 11 of the connecting and distributing portion 10 has a tubular portion 111, an insertion hole 112 on the inner circumference of the tubular portion 111, and a flange portion 113.

For example, the inner diameter of the tubular portion 111 has a shape that matches the tubular tip 87 of the injection cylinder 84, and the flange portion 113 is formed so that the outer circumference of the tubular portion 111 is larger than that of the tubular portion 111.

In the example of FIG. 5, the flange portion 113 extends outward longer in the width direction (longitudinal direction), but the collar portion 113 extends in the depth direction (short direction). ), It may extend for a long time so as to protrude from the outer circumference of the tubular portion 111.

Further, the main body portion 12 of the connecting distribution portion 10 includes a horizontal wall 121, an inclined wall 122, and a side wall 123 as outer walls. Further, as shown in FIG. 4B, the main body portion 12 is provided with an inner upper wall surface 124 which is an upper surface of the mounting space S, and the inner upper wall surface 124 has an inlet communicating from the insertion hole 112 of the mounting collar 11. A flow path 125 is formed.

As shown in FIGS. 5A and 5C, the outer diameter D111 of the tubular portion 111 of the mounting collar 11 is substantially equal to the depth D12 of the main body portion 12 in the connection distribution unit 10. Therefore, a part of the outer peripheral wall of the tubular portion 111 of the mounting collar 11 is flush with the outer surface of the side wall 123 on the long side of the main body. The depth D12 of the main body portion 12, which is the short side of the connected distribution portion 10 in the top view, is, for example, 4 mm to 7 mm.

Further, the width direction length W12 of the main body portion 12, which is the long side of the connection distribution portion 10 in the top view, is, for example, 15 mm to 30 mm. As an example, FIG. 5 shows an example of a ratio in which the depth D12 of the main body 12 is 5.6 mm and the width direction length W12 of the main body 12 is 25 mm.

Further, referring to FIG. 5D, the inner upper wall surface 124 is formed with a flow path groove 126 recessed in an upward band shape extending in the longitudinal direction. The length LG in the width direction of the flow path groove 126 is the distance between the farthest positions on the outer circumference of the needles 3a and 3e that are the farthest in the width direction among the plurality of needles 3a to 3e fixed by the needle support portion 20. It is substantially equal to Dn (see FIG. 6A).

Further, engaging recesses 127f and 127g are formed on the inner surface of the side wall 123 of the mounting space S of the main body 12.

FIG. 6 is an explanatory view of the needle support portion 20. In the needle support portion 20 of FIG. 6, (a) is a plan view, (b) is a front view, (c) is a side view, and (d) is a bottom view. Note that FIGS. 4 and 6 show a state in which the needles 3a to 3e are removed from the needle support portion 20.

In the example shown in FIG. 6, five needles 3a to 3e can be fixed in the needle support portion 20, and I22 (see FIG. 6D), which is the center spacing of the needles 3a to 3e, is 3 mm to 7 mm. is there.

Further, as shown in FIGS. 6 (b) and 6 (c), the nozzles 22a to 22e have a tapered shape that tapers toward the tips of the needle tubes 3a to 3e. Due to this shape, the nozzles 22a to 22e are less likely to come into contact with the skin even when the syringe 80 is punctured at an angle, and the nozzles 22a to 22e are less likely to interfere with the hair even if the skin has hair.

With reference to FIGS. 3 (b) and 4 (b), the nozzles 22a to 22e and the frame 21 are integrally formed. The outer diameter OD of the nozzle 22 is, for example, 2 mm to 4 mm. As an example, FIG. 3 shows an example of a ratio in which I22, which is the center distance between the needles 3a to 3e, is 5 mm and the outer diameter of the nozzle is 3.5 mm.

Further, on the outer surface of the frame 21 in the lateral direction, engaging projections 212f, 212g that engage with the engaging recesses 127f, 127g of the mounting space S are provided. In this example, an example is shown in which the engaging recesses 127f and 127g are provided on the mounting space S side and the engaging projections 212f and 212g are provided on the frame 21 side, but the shape of the engaging portion is the mounting space S side. May be provided with an engaging protrusion and an engaging recess may be provided on the frame 21 side.

As shown in the enlarged view of FIG. 4C, the upper needle holes 211a to 211e into which the needle tubes 3a to 3f are inserted in the nozzles 22a to 22e become thicker as the distance from the syringe 80 increases, and the lower needle holes 221a. ~ 221e are formed so as to provide a little play with respect to the needles 3a to 3e. In this way, by gradually thickening the hole for fixing the needle toward the tips of the needles 3a to 3e, the force of the needle can be released when pressure is applied from the outside.

Further, in the nozzle 22, the circumference 222 of the hole from which the needle protrudes is inclined so as to be recessed in an inverted pot shape (mountain shape) toward the hole. By being inclined in this way, it is possible to bend the needles 3a to 3e when an external pressure is applied and prevent the needles 3a to 3e from breaking. Further, by forming the peripheral 222 in the recess, the adhesive having fluidity can be applied into the needle holes 211a to 211e through the recess.

In the needle support portion 20 of the present invention having the above configuration, as shown in FIG. 3, the root portions of the plurality of needles 3a to 3e are collectively supported by the frame body 21, and the central portions of the needles 3a to 3e are plurality. Since the nozzles 22a to 22e are independently supported one by one and the tip portion is open, it is possible to prevent the needles from being damaged when an external force is applied to the needles 3a to 3e.

FIG. 7 is a perspective explanatory view of the attachment of the connecting distribution portion 10 and the needle support portion 20. In FIG. 7, (a) is an upward perspective view, and (b) is a downward perspective view.

Further, by connecting the connection distribution unit 10 and the needle support portion 20 as described above, in the connected state, the flow path groove 126 of the inner upper wall surface 124 of the mounting space S of the main body portion 12 of the connection distribution unit 10 (FIG. 5 (d)) and the portion surrounded by the upper surface 213 of the frame 21 of the needle support portion 20 becomes the distribution flow path of the contents.

In this example, the flow path groove 126 is formed on the inner upper wall surface 124 side of the mounting space S of the upper connection distribution portion 10, and the distribution flow path is formed by being sandwiched between the upper surface 213 of the flat plate-shaped frame 21. However, by forming a flow path groove that is recessed downward in a band shape on the upper surface 213 of the lower frame body 21, the flow path groove portion is recessed and sandwiched from both sides to distribute the flow. The road may be formed thicker. Alternatively, a flow path groove can be formed by forming a flow path groove that is recessed downward in a band shape on the upper surface 213 and sandwiching the inner upper wall surface 124 of the mounting space S of the connection distribution portion 10 in a flat plate shape. ..

Here, the injection needle assembly 1 of the present invention uses a thermoplastic resin such as polycarbonate, polypropylene, ABS resin (Acrylonitrile Butadiene Styrene copolymer synthetic resin), and polystyrene as a material, and is connected and distributed and a needle support by injection molding or the like. After manufacturing 20 separately, it is assembled and manufactured. Therefore, since the connection distribution unit 10 and the needle support portion 20 are separately injection-formed with resin, the degree of freedom of the mold of each component is increased, so that fine processing becomes possible, and the connection distribution unit Since the 10 and the needle support portion 20 can be miniaturized, the entire injection needle assembly 1 can be miniaturized.

<Cap configuration>
FIG. 8 is an explanatory view of the cap 40. In FIG. 8, (a) is a front sectional view of the cap 40, and (b) is a side sectional view. The cap 40 includes a fixing portion 41 and a cover portion 42.

A rib 413 is formed on the inner wall side of the fixing portion 41, and when the cap 40 is attached to the injection needle assembly 1, the fixing portion 41 comes into contact with the outside of the side wall 123 of the connecting distribution portion 10. Is fixed. Further, referring to FIG. 8B, the edge portion of the fixing portion 41 is an inclined end portion 412 that is inclined so that the outside becomes long.

Further, the cover portion 42 is formed to have a smaller cross-sectional area than the fixed portion 41, and the outsides of the nozzles 22a to 22e and the needle tubes 3a to 3e are put together in non-contact with the nozzles 22a to 22e and the needle tubes 3a to 3e. It is structured to cover.

<Example of the first experiment>
A comparative experiment of dead volume in an injection needle assembly performed by the present inventor will be described.

FIG. 9 is a diagram illustrating a single-needle injection needle 90 of a comparative example and a multi-needle type injection needle assembly of a first configuration example of the present invention in the first experimental example.

As shown in the photograph of FIG. 9B, the single needle of the comparative example is a single needle of 27 G (gauge), and the outer diameter φ of the needle is 0.4 mm, the inner diameter φ is 0.22 mm, and the inner diameter area is It is 0.058 mm ² . The wave surface angle, which is the inclination of the tip of the needle, was 9 °, and the wave surface length was 2 mm.

In the single needle type injection needle 90 of the comparative example having such a configuration, the weights of the injection needle 90 before use and the injection needle 90 after injection of the contents were compared and measured, and the needle base of the injection needle 90 was measured. The dead volume of the contents remaining in the 91 and the needle tube 92 was 0.0159 g.

On the other hand, the multi-needle of the present invention is a 31G 5-needle, the outer diameter φ of the needle is 0.26 mm, the inner diameter φ is 0.16 mm, and the inner diameter area is 0.02 mm ² × 5 needles. The total is 0.1 mm ² . The wave surface angle, which is the inclination of the tip of the needle, was 12 °, and the wave surface length was 0.7 mm.

In the multi-needle type injection needle assembly 1 of the present invention having such a configuration, the weights of the injection needle assembly 1 before use and the injection needle assembly 1 after injection of the contents were compared and measured. The dead volume in which the contents remained in the inlet flow path 125, the distribution flow path, and the needle tubes 3a to 3e in the assembly 1 was 0.0586 g.

In the multi-needle type injection needle assembly 1 of the present invention, the dead volume is larger than that of the single-needle type injection needle 90. However, considering that there is a difference between the 1-needle and the 5-needle, the dead volume of the injection needle assembly, which is 5 needles, is less than 5 times that of the 1-needle injection needle 90, and the needles. The dead volume per one is as small as about 73% of the comparative example.

Further, in this configuration of the present invention, the backflow (backflow of contents) is caused by the wave surface length, which is the notch length of the hole at the tip of the needle tube 3a, being shorter than that of the comparative example, as compared with the configuration of the comparative example. Can be prevented. Further, in this configuration, since the needle tubes 3a to 3e are thinner than the needles of the comparative example, the pain due to puncture can be reduced.

Further, in this configuration of the present invention, since the total inner diameter area of the needle tubes 3a to 3e is larger than that of the single needle, the fluid resistance when injecting by pressing the pusher 88 is reduced, and the clogging resistance is reduced. can do.

<Example of the second experiment>
Next, a comparative experiment of pain will be described using a comparative example conducted by the present inventor and one configuration of the present invention.

FIG. 10 is a diagram showing the implementation conditions of the comparative example in the second experimental example.

In the comparative example shown in FIG. 10, the injection amount per unit is 1 mL corresponding to one syringe, which is divided into 6 times, and 166 μL is injected each time. The needle of the injection needle attached to the syringe is 27 G, the injection liquid volume per area is 1 mL / 2 cm ² , and the total injection area is 8 cm ² .

Specifically, in the comparative example, in order to inject 1 mL, as shown in FIG. 10 (b), one unit is to inject 166 μL at 6 locations concentrically within a range of about 2 cm ² . Inject 4 mL of the drug solution into the subject to perform the operation at 4 different positions. Injecting a total volume of 4 mL This entire injection operation will be 24 times.

FIG. 11 is a diagram showing the implementation conditions of the present invention in the second experimental example.

As shown in FIG. 11, in the present invention, the injection amount per unit is 1 mL, which corresponds to one syringe, and 166 μL is injected in 6 divided doses, as in the comparative example. Further, the number of needles (needle tubes 3a to 3e) of the injection needle assembly 1 of the present invention, which is a multi-needle, is 5 at 31G. The injection liquid volume per area is 1 mL / 10 cm ² , and the total injection area is 40 cm ² .

Specifically, in the present invention, in order to inject 1 mL, as shown in FIG. 11 (b), 166 μL can be injected at 6 locations in a range of about 10 cm ² while shifting in the vertical or horizontal direction. When a total volume of 4 mL is injected, the injection operation is 24 times as shown in FIG. 11 (c), and the injection can be performed within the range of 40 cm ² .

In any of the operations shown in FIGS. 10 and 11, in the injection operation, the needles 3a to 3e were brought into the skin about 4 mm subcutaneously from the needle tip.

In the injection needle assembly 1 of the present invention, as described above, a plurality of needle tubes 3a to 3e are arranged in one direction, so that the needle tubes 3a to 3e are punctured in a state of being tilted with respect to the skin. The contents can be administered. Therefore, for example, as shown in FIG. 10 (c), even when the content is administered to the scalp on which the hair has grown, the hair can be injected linearly while being punctured, so that, for example, in a radial pattern or , Unlike an assembly with multiple needles arranged in a polygonal shape or arranged vertically and horizontally, the hair is less likely to interfere with the puncture. Therefore, in the configuration of the present invention, the contents can be easily and widely administered even on the skin in which hair is present.

FIG. 12 is a diagram showing a comparative example and a pain measurement result of the present invention in the second experimental example.

Here, the injection needle that injects the liquid is
It is performed in the order of (1) puncture (entry into the skin by advancing the needle), ⇒ (2) retreating the needle + injecting the drug solution, and ⇒ (3) removing the needle.

Of these, it is generally considered that pain occurs during the puncture of (1) and the injection of the drug solution of (2).

Therefore, for three subjects, using the single-needle injection needle of the comparative example shown in FIG. 9 and the multi-needle injection needle assembly 1 of the present invention, 4 mL as shown in FIGS. 10 and 11. The evaluation result of the pain when the drug solution of No. 1 was injected is shown in FIG.

As shown in FIG. 12, the puncture pain is more in the present invention than in the comparative example. It is considered that this is because many needles are punctured at one time in the configuration of the present invention.

On the other hand, injection pain is less in the present invention than in the comparative example. It is considered that this is because the amount of the chemical solution injected from one needle is small in the configuration of the present invention.

Further, according to the table of FIG. 12, the injection pain of the comparative example is larger than the puncture pain of the present invention. Therefore, by using the multi-needle injection needle assembly of the present invention, pain can be reduced as a whole as compared with the single-needle injection needle of the comparative example.

<Example of the third experiment>
In addition, the present inventor measured the uniformity when ejecting the contents from the five needles.

FIG. 13 is a graph showing the discharge amount of each needle when water is discharged and the average discharge amount of each time in the multi-needle type injection needle assembly 1 of the present invention in the third experimental example. A to e in the graph of FIG. 13A correspond to the discharge amounts discharged from the needle tubes 3a to 3e, respectively.

In this example, by manually operating the pusher 88 of the injection tube 84, the contents are used up four times, that is, the total amount of water is 1 mL, and the amount of water discharged is arbitrary. Was discharged onto the sheet four times. Then, as for the discharge amount, the weight of the water droplets discharged on the sheet was measured.

In the first, second, and third times shown in FIG. 13A, the discharge amounts of the needles 3a and 3e on both end sides are slightly larger, and the discharge amounts of the needles 3c on the center side are slightly smaller. Also, at the 4th time, there is a slight variation without increasing the number of both ends.

However, as shown in FIG. 13B, the variation is about 5% of the discharge amount, and it can be seen that the larger the discharge amount, the smaller the variation ratio.

FIG. 14 is a graph showing the discharge amount of each needle when the cells are discharged and the average discharge amount of each time in the multi-needle type injection needle assembly 1 of the present invention in the third experimental example. A to e in the graph of FIG. 14A correspond to the discharge amounts discharged from the needle tubes 3a to 3e, respectively.

In this example, by manually operating the pusher 88 of the injection tube 84, the contents are used up in 5 times, that is, the total amount is 1 mL, with the discharge amount of an arbitrary pressing operation. The cell fluid was discharged 5 times. Then, as for the discharge amount, the weight of the droplets of the extracellular fluid discharged on the sheet was measured. The extracellular fluid shown in FIG. 14 has a higher viscosity than the water shown in FIG.

As shown in FIG. 14A, in the case of a small amount of discharge in the first, second, third, fourth, and fifth times, the discharge amount of the needles 3a and 3e on both ends tends to be slightly larger. The number of needles 3c on the center side is slightly reduced.

In the case of extracellular fluid as well, the variation is about 5% of the discharge amount.

Further, as compared with FIGS. 13 and 14, the extracellular fluid having a high viscosity has slightly less variation in discharge than the case of water. It is considered that the cell fluid has a higher viscosity.

As described above, as shown in FIGS. 13 and 14, in the injection needle assembly of the present invention, a small amount of contents is ejected from each needle little by little with little variation between the five needles and in almost equal amounts. It turns out that it can be made to.

As described above, the multi-needle type injection needle assembly of the present invention can be miniaturized and a small amount of sample can be administered with reduced pain during injection.

The content (substance) used in the syringe to which the needle assembly is connected according to the embodiment of the present invention described above is a cell suspension, a gel-like material, a therapeutic substance, a cosmetic substance, and a diagnostic substance. It can be selected from the constituent groups. For example, the content (substance) used in the syringe can be selected from the group consisting of cell suspensions, gel materials, therapeutic substances, cosmetic substances, and diagnostic substances.

Cosmetic substances to be injected may include, but are not limited to, adipocytes such as filler, hyaluronic acid, or botulinum toxins (Botox, Btx) in the treatment of wrinkles. Therapeutic substances may include, but are not limited to, antibiotics, anesthetics, analgesics, vaccines, antibodies.

In addition, the needle assembly of the present invention may be used to inject into a subject the cells in a suspension or cells in a liquid medium as the contents contained in a syringe.

In addition, cell suspensions may be mixed with growth factors as the contents contained within the syringe. Alternatively, the cell suspension may contain a gel-like structure. Such a gel-like structure preferably represents a mixture of extracellular matrix proteins that mimic the extracellular environment of distinct tissues, and more preferably a gel-like structure such as hyaluronic acid.

In addition, the needle assembly according to the embodiment of the present invention may be used to inject the substance into a separate tissue of the subject. Needle assembly for injection of cells into the skin as a cell suspension, especially in the treatment of alopecia such as hair loss, alopecia areata, or other symptoms associated with lack of hair or too little hair. Can be used.

Also, the needle assembly of the present invention is preferably used to inject a liquid, such as a drug, cytokine, or growth factor, into a subject. This application of the liquid to the subject is preferably made in connection with the treatment of alopecia such as hair loss, alopecia areata, or other symptoms associated with lack of hair or too little hair.

Alternatively, the needle assembly according to an embodiment of the present invention may be used to inject a substance into a subject's muscle or into a subject's tendon. In that case, set the length of the needle so that it reaches the muscles and tendons.

Further, the subject to which the injection device according to the embodiment of the present invention is applied is not limited to a human (subject), but may be an animal such as a fish or a mouse. Alternatively, the subject may be a tissue such as skin or an organ taken from the subject or the subject animal.

Although the preferred embodiment of the present invention has been described in detail above, the present invention is not limited to the specific embodiment, and is within the scope of the gist of the embodiment of the present invention described in the claims. Various modifications and changes are possible.

1 Injection needle assembly 3a, 3b, 3c, 3d, 3e Needle tube (needle)
10 Connecting and distributing part 11 Mounting collar 111 Cylindrical part 112 Insertion hole 113 Collar part 12 Main body part 121 Horizontal wall 122 Inclined wall 123 Side wall 124 Inner upper wall surface 125 Inlet flow path 126 Flow path groove 127f, 127g Engagement recess (engagement part)
21 Frame body 211 Upstream needle hole 212f, 212g Engagement protrusion (engagement part)
22a to 22e Nozzle 221 Downstream needle hole 40 Cap 41 Fixing part 42 Cover part 80 Syringe 84 Injection cylinder 87 Cylinder tip (tip)
88 pusher (plunger)
X Short direction (depth direction)
Y Longitudinal direction (width direction)
Z injection direction

Claims (11)

A needle assembly in which the tip of a syringe is fitted to inject the contents.
A tubular mounting collar that is open to one end so that the tip of the tip of the injection tube is fitted, and the other end of the mounting collar is connected to one end in the width direction from the outer diameter of the mounting collar. A connecting and distributing part having a main body part that extends to the other side and has an opening at the other end to serve as a mounting space.
A plurality of nozzles for fixing a plurality of needles in a lined state in the width direction, and one end side of the connecting and distributing portion are fitted and fixed inside the mounting space of the main body portion, and the plurality of needles are fixed from the other end side. A needle support portion having a frame body surrounding a part of the plurality of nozzles is provided so that the nozzles project.
Needle assembly. The connection distribution unit is formed with an inlet flow path that communicates with the inside of the insertion hole of the mounting collar.
In a state where the connecting distribution part and the needle support part are connected
The inner upper wall surface of the mounting space of the main body portion of the connecting distribution portion and the portion surrounded by the upper surface of the needle support portion serve as a distribution flow path for the contents.
The injection needle assembly according to claim 1. An upwardly recessed flow path groove is formed in the inner upper wall surface of the mounting space of the main body portion of the connection distribution portion, and the length of the flow path groove in the width direction is determined by the needle support portion. Of the plurality of fixed needles, the distance between the farthest positions on the outer circumference of the farthest needle in the width direction is substantially equal to.
The injection needle assembly according to claim 2. The height from the upper end to the lower end of the frame body of the needle support portion is substantially equal to the height of the mounting space of the main body portion.
The injection needle assembly according to claim 2 or 3. The height of the frame body of the needle support portion and the height of the mounting space of the connection distribution portion are 0.5 mm to 3.0 mm.
The injection needle assembly according to claim 4. An engaging portion is formed on the outer wall of the frame body of the needle support portion, and an engaging portion is formed on the side wall of the mounting space of the main body portion.
The invention according to any one of claims 2 to 5, wherein the engaging portion of the frame body and the engaging portion of the mounting space are engaged when the needle support portion and the connecting / distributing portion are connected. Injection needle assembly. The injection according to any one of claims 1 to 6, wherein in the connecting distribution portion, a part of the outer peripheral wall of the tubular portion of the collar portion is flush with the outer surface of the side wall of the long side of the main body portion. Needle assembly. The long side of the connected distribution unit in view of the upper surface is 15 mm to 30 mm.
The injection needle assembly according to any one of claims 1 to 7, wherein the short side in top view is 4 mm to 7 mm. The injection needle assembly according to any one of claims 1 to 8, wherein the needle and the nozzle are five, and the distance between the plurality of needles is 3 mm to 7 mm. The thickness of each nozzle is 2 mm to 4 mm.
The thickness of the plurality of needles is 18G to 34G.
The injection needle assembly according to any one of claims 1 to 9. Each of the nozzles has a tapered shape that tapers toward the tip of the needle.
The injection needle assembly according to any one of claims 1 to 10.